{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-023522","form_type":"8-K","ticker":"CVRX","cik":"0001235912","company_name":"CVRx, Inc.","filed_at":"2023-02-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:44.135060+00:00","generated_at":"2026-06-19T06:30:20.168154+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CVRx BeAT-HF trial misses primary endpoint; positive secondary analyses support Barostim label expansion plan","bullets":["Trial of 323 HFrEF patients did not reach statistical significance on primary composite endpoint of CV mortality and HF morbidity.","Prespecified analyses favored Barostim: all-cause survival free from LVAD/transplant, Win Ratio analysis, clinical stability.","Safety and symptomatic improvement at 6 months durable through 24 months.","Company plans to submit totality of evidence to FDA for expanded Barostim labeling.","Data to be presented at THT conference on March 21, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-023522","json":"https://secwatch.observer/filing/0001104659-23-023522.json","markdown":"https://secwatch.observer/filing/0001104659-23-023522.md","text":"https://secwatch.observer/filing/0001104659-23-023522.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1235912/000110465923023522/0001104659-23-023522-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1235912/000110465923023522/tm237383d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T06:30:20.168154+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}